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Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03331458
Acronym
PACMen
Enrollment
13
Registered
2017-11-06
Start date
2018-04-17
Completion date
2019-03-21
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

physical activity

Brief summary

Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment. The purpose of this study is to 1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and 2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe: 1. Examine intervention safety and tolerance by self-report 2. Examine changes in functional capacity by 6-minute walk test 3. Examine changes in symptom experience by self-report

Interventions

BEHAVIORALexrecise intervention

Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed with prostate cancer * will not start treatment for at least 2 weeks * able to read and understand English * capable of giving informed consent * at least 18 years old

Exclusion criteria

* patients who are incompetent for interview (documented diagnosis of active psychosis or dementia) * unable to provide informed consent as assessed by the interviewer * too sick to participate, as judged by a member of the research team or the exercise physiologist * have been treated for another cancer

Design outcomes

Primary

MeasureTime frameDescription
Change in 6 minute walk testbaseline, 2 weeks post interventionDistance walked in 6 minutes
Change in balance testbaseline, 2 weeks post interventionAbility to balance
Change in time up to go testbaseline, 2 weeks post interventionTime to get up from chair, walk 30 meters and return to sit in chair
Change in Godin Leisure Time Scorebaseline, 2 weeks post interventionphysical activity score
Change in rate of perceived exertionbaseline, 2 weeks post interventionphysical exertion score
Change in metabolic equivalentbaseline, 2 weeks post interventionmetabolic activity score
Change in distress scorebaseline, 2 weeks post interventiondistress score
Change in self-efficacy scorebaseline, 2 weeks post interventionself-efficacy score
Change in symptom inventory scorebaseline, 2 weeks post interventiondescription of symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026